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Seltorexant for Depression

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT) diagnosed with first depressive episode prior to age 60. The length of the current depressive episode must be less than or equal to (<=) 24 months prior to randomization
Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (<) 50 percent (%) reduction but with some improvement (that is, improvement greater than [>] 0%) in depressive symptom severity with residual symptoms beyond insomnia present, and overall good tolerability, as assessed by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether seltorexant can improve depressive symptoms in people with MDD who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI. The trial will also assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in people with MDD.

Who is the study for?
Adults with major depressive disorder and insomnia who haven't improved enough on SSRIs or SNRIs can join. They must have a BMI of 18-40, stable health, no severe mental disorders like bipolar or psychosis, no serious sleep disorders other than insomnia, and not be at high risk for suicide.Check my eligibility
What is being tested?
The trial is testing Seltorexant as an add-on to antidepressants against a placebo in people whose depression-related insomnia hasn't improved much with current treatments. It also looks at the long-term safety of Seltorexant.See study design
What are the potential side effects?
Possible side effects aren't specified here but generally could include typical drug reactions such as nausea, headaches, dizziness, fatigue or more specific effects related to mood and sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with depression without psychosis, first noticed before I was 60, and it has lasted no more than 24 months.
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I've tried 1-2 antidepressants for my current depression episode without enough improvement.
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I've been taking a specific antidepressant without issues for 6 weeks to 18 months.
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My recent health checks, including heart tests, show I am medically stable.
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I have been diagnosed with depression without psychosis, first noticed before I was 60, and it has lasted no more than 24 months.
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I've tried 1-2 antidepressants without enough improvement in my current depression episode.
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I've been taking a specific antidepressant without issues for 6 weeks to 18 months.
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My recent health checks, including heart tests, show I am medically stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Double-blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
OL Treatment Phase: Change From Baseline in Blood Pressure
OL Treatment Phase: Change From Baseline in Body Mass Index (BMI)
+12 more
Secondary outcome measures
DB Treatment Phase: Change From Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score
DB Treatment Phase: Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score
DB Treatment Phase: Change From Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SeltorexantExperimental Treatment1 Intervention
Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (Up to 1 Year).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seltorexant
2021
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,207 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,320 Total Patients Enrolled

Media Library

Seltorexant Clinical Trial Eligibility Overview. Trial Name: NCT04533529 — Phase 3
Major Depressive Disorder Research Study Groups: Seltorexant, Placebo
Major Depressive Disorder Clinical Trial 2023: Seltorexant Highlights & Side Effects. Trial Name: NCT04533529 — Phase 3
Seltorexant 2023 Treatment Timeline for Medical Study. Trial Name: NCT04533529 — Phase 3
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04533529 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that we hope to achieve with this research?

"The main goal of this clinical trial is to measure the effect of the treatment on participants' sexual function, as measured by the Arizona Sexual Experiences Scale (ASEX) score. The trial will also track changes in participants' depression symptoms (as measured by the MADRS-6 scale), sleep quality (as measured by the PROMIS-SD), and overall symptoms of depression (as measured by the MADRS-WOSI scale)."

Answered by AI

Does this clinical research involve seniors who are 75 years old or older?

"The age requirements to participate in this clinical trial are 18 to 74. However, if you are outside of this age range, there may be other trials more suited for you as 202 trials exist for those under 18 and 986 for those over 65."

Answered by AI

To whom does this experiment extend an invitation?

"This trial is looking for 550 patients that have involutional psychosis and are between 18 and 74 years old. Most importantly, potential participants must meet the following requirements: Be diagnosed with major depressive disorder (MDD) without any psychotic features, according to the Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5), Have a current depressive episode that is shorter than 24 months, Be tolerating and responding well to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms, Have a body mass index (BMI) between"

Answered by AI

How many total people are taking part in this clinical research project?

"In order for this clinical trial to move forward, 550 people who fit the pre-determined inclusion criteria need to sign-up. Those interested can participation from Haidar Almhana Nieding in Avon Lake, Ohio and American Medical Research, Inc. in Oak Brook, Illinois."

Answered by AI

Does Seltorexant have a history of successful clinical trials?

"Universitaetsklinikum der RWTH Aachen first began to study seltorexant in 2020. To date, there have been 18253 completed trials and 6 that are still recruiting patients. The majority of these remaining trials are taking place in Avon Lake, Ohio."

Answered by AI

Has Seltorexant received FDA approval for use?

"Seltorexant is a Phase 3 trial drug, meaning that while there is some efficacy data, there is mostly safety data. Our team rates it a 3."

Answered by AI

Are people still being recruited for this clinical trial?

"Yes, the information available on clinicaltrials.gov indicates that this particular clinical trial is currently recruiting patients. This trial was first posted on September 16th, 2020, and was last updated on October 12th, 2020. The study is looking for 550 participants across 45 different locations."

Answered by AI

Has this clinical trial been attempted before?

"Seltorexant was first studied in 2020 by Janssen Research & Development, LLC. The Phase 1 clinical trial involved 64 patients. Following the success of the first study, Seltorexant received approval as a Phase 1 drug. Presently, there are 6 active trials being conducted in 132 cities and 28 countries."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Ohio
Other
Florida
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania - Perelman School of Medicine
Baylor College of Medicine
Haidar Almhana Nieding
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I also have PTSD. Tried meds, therapy, ect, tms, spravato, ketamine. I’m in a major depression episode, it’s not my first, I would like to make them less.
PatientReceived 2+ prior treatments
I’ve tried over 5 different drugs over the last 5 years. I’m tired of being depressed.
PatientReceived no prior treatments
I've tried MANY drugs without lasting benefits during the past 35+ years. I haven't given up hope though I want to see if there is something new that could help.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Synexus Clinical Research US, Inc: < 48 hours
Average response time
  • < 2 Days
~131 spots leftby Mar 2025